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Rosuvastatin in Visceral Adiposity (RIVIERA)

Primary Purpose

Abdominal Obesity

Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Rosuvastatin
Placebo for rosuvastatin
Sponsored by
Göteborg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Obesity

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male patients between 40 and 65 years of age.
  • Abdominal obesity
  • Dyslipidemia
  • Written informed consent.

Exclusion Criteria:

  • Uncontrolled hypertension
  • Diabetes mellitus
  • Severe liver disease
  • Severely reduced renal function
  • Uncontrolled endocrine disorders
  • History of or ongoing malignant disease
  • Patients with known myopathic disease
  • Recent alcohol or drug abuse
  • Weight loss or weight gain during the three months prior to screening.
  • Ongoing treatment with statins
  • Ongoing treatment with calcineurin-inhibitors
  • Ongoing treatment with anti-inflammatory drugs
  • Received an investigational drug within 30 days prior to screening.
  • Strong clinical indication for statin treatment
  • In the Principal Investigator's opinion, the patient has other clinically significant cardiac, oncologic, neurologic or psychiatric disease that could be adversely affected by Study participation.
  • For any reason the patient is considered by the Principal Investigator to be an unsuitable candidate to participate in the Study.

Sites / Locations

  • Department of Molecular and Clinical Medicine, Sahlgrenska Academy at University of Gothernburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Rosuvastatin

Placebo for Rosuvastatin

Arm Description

Outcomes

Primary Outcome Measures

Change in Visceral Adipose Tissue Area Measured by Computed Tomography.

Secondary Outcome Measures

Change in Subcutaneous Adipose Tissue Area
Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT.
Change in Hepatic Fat Infiltration Measured by CT.
Change in Body Weight
Change in LDL

Full Information

First Posted
February 12, 2010
Last Updated
August 6, 2015
Sponsor
Göteborg University
Collaborators
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT01068626
Brief Title
Rosuvastatin in Visceral Adiposity
Acronym
RIVIERA
Official Title
A 26-week, Single Center, Randomized, Placebo-controlled, Double-blind, Parallel-group Study to Evaluate the Effect of Rosuvastatin on Visceral Adipose Tissue in Male Patients With Abdominal Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Göteborg University
Collaborators
Sahlgrenska University Hospital, Sweden

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate whether 6 months treatment with the cholesterol-lowering drug rosuvastatin may reduce visceral fat tissue in obese middle aged men.
Detailed Description
The accumulation of intra-abdominal fat has been suggested to be of primary importance in the development of the metabolic syndrome and associated metabolic disturbances and it has been hypothesized that a selective reduction of visceral fat tissue would improve the symptoms of the metabolic syndrome. Treatment with statins decrease levels of LDL-cholesterol and reduce coronary artery disease (CAD) events. Although it is widely accepted that the majority of benefit obtained with statins is a direct result of their lipid-lowering properties, they also demonstrate additional cholesterol-independent or pleiotropic effects. The results of experimental studies have now shown that statins decrease fat mass in the visceral region in an animal model. In the present study, we will investigate whether statins can decrease visceral obesity in humans.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rosuvastatin
Arm Type
Active Comparator
Arm Title
Placebo for Rosuvastatin
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor®
Intervention Description
10 mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebo for rosuvastatin
Intervention Description
once daily
Primary Outcome Measure Information:
Title
Change in Visceral Adipose Tissue Area Measured by Computed Tomography.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Subcutaneous Adipose Tissue Area
Time Frame
6 months
Title
Change in the Ratio Between Intra-abdominal and Subcutaneous Tissue Area Measured by CT.
Time Frame
6 months
Title
Change in Hepatic Fat Infiltration Measured by CT.
Time Frame
6 months
Title
Change in Body Weight
Time Frame
6 months
Title
Change in LDL
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male patients between 40 and 65 years of age. Abdominal obesity Dyslipidemia Written informed consent. Exclusion Criteria: Uncontrolled hypertension Diabetes mellitus Severe liver disease Severely reduced renal function Uncontrolled endocrine disorders History of or ongoing malignant disease Patients with known myopathic disease Recent alcohol or drug abuse Weight loss or weight gain during the three months prior to screening. Ongoing treatment with statins Ongoing treatment with calcineurin-inhibitors Ongoing treatment with anti-inflammatory drugs Received an investigational drug within 30 days prior to screening. Strong clinical indication for statin treatment In the Principal Investigator's opinion, the patient has other clinically significant cardiac, oncologic, neurologic or psychiatric disease that could be adversely affected by Study participation. For any reason the patient is considered by the Principal Investigator to be an unsuitable candidate to participate in the Study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John-Olov Jansson, Prof
Organizational Affiliation
Department of Endocrinology, University of Gothenburg
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Claes Ohlsson, Professor
Organizational Affiliation
Department of Clinical Pharmocology, University of Gothenburg
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Anna Nilsson, MD, PhD
Organizational Affiliation
Department of Endocrinology, University of Gothenburg
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kristjan Karason, MD, PhD
Organizational Affiliation
Department of Molecular and Clinical Medicine at University of Gothenburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Molecular and Clinical Medicine, Sahlgrenska Academy at University of Gothernburg
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden

12. IPD Sharing Statement

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Rosuvastatin in Visceral Adiposity

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